Brand Name | NA |
Type of Device | ELECTRODE, PACEMAKER, TEMPORARY |
Manufacturer (Section D) |
MEDTRONIC, INC. |
8200 coral sea street ne |
mounds view MN 55112 |
|
Manufacturer (Section G) |
MEDTRONIC, INC. |
8200 coral sea street ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 6468085 |
MDR Text Key | 72201410 |
Report Number | 2182208-2017-00503 |
Device Sequence Number | 1 |
Product Code |
LDF
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K923407 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/25/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 5833SL |
Device Catalogue Number | 5833SL |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/22/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/25/2017 |
Initial Date FDA Received | 04/06/2017 |
Supplement Dates Manufacturer Received | 01/25/2017
|
Supplement Dates FDA Received | 09/29/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | 5076-58 LEAD |
Patient Outcome(s) |
Required Intervention;
|
|
|